Status:
COMPLETED
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chemotherapy-Induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy ...
Eligibility Criteria
Inclusion
- Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
- Karnofsky score of 60 or greater
Exclusion
- Patient is scheduled to receive any dose of cisplatin
- Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
- Any allergies to study drug or antiemetics
- Taking CYP3A4 substrates/prohibited medication
- Significant medical or mental conditions
- Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2008
Estimated Enrollment :
848 Patients enrolled
Trial Details
Trial ID
NCT00337727
Start Date
January 1 2007
End Date
November 19 2008
Last Update
June 2 2017
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